Bariatric Nutritional Intervention in Obese Patients with Compensated Liver Cirrhosis: A Four-Year Prospective Study.

BACKGROUND: Obesity and liver cirrhosis represent significant health challenges, often leading to various complications. AIMS: This prospective study aimed to investigate the impact of a four-year bariatric intervention, focusing on adherence to the Mediterranean Diet, on anthropometric, hematologic, and biochemical parameters in obese patients with compensated liver cirrhosis. Additionally, the study evaluated the concurrent contribution of weight loss to these health indicators. METHODS: The study involved 62 patients with compensated liver cirrhosis (mean age 65.87 ± 6 years) and 44 healthy controls (mean age 59.11 ± 8 years), all with a BMI > 30 kg/m2. Both groups underwent a weight loss intervention based on the Mediterranean diet, with a four-year follow-up. Anthropometric, biochemical and hematologic parameters were evaluated at several time points during the study and their statistical significance was assessed. RESULTS: Anthropometric parameters, including weight, BMI, waist and hip circumference, percentage of fat mass, and handgrip strength, exhibited significant improvements (p < 0.05), particularly within the first year of the intervention. Liver function tests and lipid profiles of the patients also showed significant enhancements (p < 0.05). Hematological and biochemical indices, such as hematocrit and ferritin, experienced discreet improvements in the patient cohort (p < 0.05). CONCLUSIONS: This study highlights the potential of a structured bariatric intervention rooted in the Mediterranean diet to positively influence the health of obese patients with compensated liver cirrhosis. The observed improvements in anthropometric, biochemical, and hematologic parameters, particularly within the first year of the intervention, suggest the importance of dietary modifications in managing the health of this patient population.

Safety and Risk in Airway Management During Bariatric Air Medical Retrieval.

OBJECTIVE: Bariatric anatomy and physiology present added clinical challenges to the provision of safe critical care and patient transport. LifeFlight Retrieval Medicine provides air medical retrieval services in Queensland, Australia, and performs over 6,000 retrieval missions annually using rotary wing, fixed wing, and ground ambulance platforms. METHODS: Bariatric patient retrievals were identified from the LifeFlight Retrieval Medicine electronic patient database. These cases were interrogated to quantify and describe adverse events during patient transport. RESULTS: Over the study period from July 2019 to December 2021 11,096 patient retrievals were completed. Of these patients, 816 (7.3%) had a body weight ≥ 120 kg (range, 120-246 kg; median = 146 kg). Bariatric patients were more likely to be male (70%) and to require critical care interventions than nonbariatric patients (25.9% vs. 19.9%). There was an absolute 1.5% increase of high-interest events during patient retrieval, corresponding to a 1.9-fold increased relative risk. Five hundred eleven of 11,096 patients were intubated by the retrieval team, and 61 of these weighed ≥ 120 kg. Bariatric patients undergoing intubation were of similar age and sex, weighed significantly more, had nonsignificant trends toward poorer airway visualization by Cormack-Lehane laryngoscopic grade, and tended toward reduced first-attempt success compared with nonbariatric patients. Rates of airway adverse events (AAEs) were significantly increased for the bariatric group (30/61, 49.2%) compared with the nonbariatric group (135/450, 30.0%) (χ2 likelihood ratio, P = .004). Postintubation desaturation was the most common AAE and was the only criterion significantly increased when comparing bariatric (26%) versus nonbariatric (12%) patients (χ2 likelihood ratio, P = .005). Using patient weight as a continuous variable, nominal logistic regression revealed a significant effect of increasing weight on AAEs (χ2 = 12.9, P = .0003) with a threshold of 105 kg providing an optimal 88% sensitivity for predicting AAEs. The odds of AAEs were increased significantly for those weighing 105 to 119 kg versus those weighing < 105 kg (odds ratio [OR] = 3.4; 95% confidence interval [CI], 1.6-7.5) and for those weighing ≥ 120 kg versus those weighing < 105 kg (OR = 2.5; 95% CI, 1.4-4.3). There was no difference between those weighing ≥ 120 kg versus those weighing 105 to 119 kg (OR = 0.73; 95% CI, 0.3-1.8). CONCLUSION: Air medical retrieval of bariatric patients is safe despite an increased risk of adverse events. Strategies to optimize emergency anesthesia should be used to maximize safe intubation in bariatric patients.

Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability.

AIM: To determine whether continuous glucose monitoring (CGM) can reduce hypoglycaemia in patients with post-bariatric hypoglycaemia (PBH). MATERIALS AND METHODS: In an open-label, nonrandomized, pre-post design with sequential assignment, CGM data were collected in 22 individuals with PBH in two sequential phases: (i) masked (no access to sensor glucose or alarms); and (ii) unmasked (access to sensor glucose and alarms for low or rapidly declining sensor glucose). Twelve participants wore the Dexcom G4 device for a total of 28 days, while 10 wore the Dexcom G6 device for a total of 20 days. RESULTS: Participants with PBH spent a lower percentage of time in hypoglycaemia over 24 hours with unmasked versus masked CGM (<3.3 mM/L, or <60 mg/dL: median [median absolute deviation {MAD}] 0.7 [0.8]% vs. 1.4 [1.7]%, P = 0.03; <3.9 mM/L, or <70 mg/dL: median [MAD] 2.9 [2.5]% vs. 4.7 [4.8]%; P = 0.04), with similar trends overnight. Sensor glucose data from the unmasked phase showed a greater percentage of time spent between 3.9 and 10 mM/L (70-180 mg/dL) (median [MAD] 94.8 [3.9]% vs. 90.8 [5.2]%; P = 0.004) and lower glycaemic variability over 24 hours (median [MAD] mean amplitude of glycaemic excursion 4.1 [0.98] vs. 4.4 [0.99] mM/L; P = 0.04). During the day, participants also spent a greater percentage of time in normoglycaemia with unmasked CGM (median [MAD] 94.2 [4.8]% vs. 90.9 [6.2]%; P = 0.005), largely due to a reduction in hyperglycaemia (>10 mM/L, or 180 mg/dL: median [MAD] 1.9 [2.2]% vs. 3.9 [3.6]%; P = 0.02). CONCLUSIONS: Real-time CGM data and alarms are associated with reductions in low sensor glucose, elevated sensor glucose, and glycaemic variability. This suggests CGM allows patients to detect hyperglycaemic peaks and imminent hypoglycaemia, allowing dietary modification and self-treatment to reduce hypoglycaemia. The use of CGM devices may improve safety in PBH, particularly for patients with hypoglycaemia unawareness.

Balancing Safety and Efficacy to Determine the Most Suitable Size of Imaging-Visible Embolic Microspheres for Bariatric Arterial Embolization in a Preclinical Model.

OBJECTIVES: To identify the most suitable size of imaging-visible embolic agents with balanced safety and efficacy for bariatric arterial embolization (BAE) in a preclinical model. MATERIALS AND METHODS: Twenty-seven pigs were divided into 3 cohorts. In Cohort I, 16 pigs were randomized to receive (n = 4 each) 40-100-µm microspheres in 1 or 2 fundal arteries, 70-340-µm radiopaque microspheres in 2 fundal arteries, or saline. In Cohort II, 3 pigs underwent renal arterial embolization with either custom-made 100-200-µm, 200-250-µm, 200-300-µm, or 300-400-µm radiopaque microspheres or Bead Block 300-500 µm with microsphere distribution assessed histologically. In Cohort III, 8 pigs underwent BAE in 2 fundal arteries with tailored 100-200-µm radiopaque microspheres (n = 5) or saline (n = 3). RESULTS: In Cohort I, no significant differences in weight or ghrelin expression were observed between BAE and control animals. Moderate-to-severe gastric ulcerations were noted in all BAE animals. In Cohort II, renal embolization with 100-200-µm microspheres occluded vessels with a mean diameter of 139 µm ± 31, which is within the lower range of actual diameters of Bead Block 300-500 µm. In Cohort III, BAE with 100-200-µm microspheres resulted in significantly lower weight gain (42.3% ± 5.7% vs 51.6% ± 2.9% at 8 weeks; P = .04), fundal ghrelin cell density (16.1 ± 6.7 vs 23.6 ± 12.6; P = .045), and plasma ghrelin levels (1,709 pg/mL ± 172 vs 4,343 pg/mL ± 1,555; P < .01) compared with controls and superficial gastric ulcers (5/5). CONCLUSIONS: In this preclinical model, tailored 100-200-µm microspheres were shown to be most suitable for BAE in terms of safety and efficacy.

Patients with bariatric surgery: Urgent need for accurate registration of the contraindication to enable safe pharmacotherapy in hospital and primary care.

PURPOSE: To enable the use of automatic clinical decision support for pharmacotherapy in patients with bariatric surgery, it is necessary to register the contraindication "bariatric surgery" in the hospital, general practitioner (GP), and community pharmacy electronic health record systems. The aim of this research was to quantify the correct registration of this contraindication in hospital, GP, and community pharmacy records. Furthermore, we investigated whether the registration status in primary care was dependent on the registration status in the hospital. METHODS: From patients who underwent bariatric procedures performed in the Albert Schweitzer Hospital (Dordrecht, the Netherlands) between 2018 and 2021, the percentage of registered contraindications in hospital medical records was assessed. Due to feasibility reasons, a subset of the patients' data was created for assessing the percentage of registered contraindications in GP and community pharmacy records. RESULTS: Out of 664 patients who underwent bariatric surgery, the contraindication bariatric surgery was registered in 69.1% of the cases. Out of 552 patients, 28.3% and 25.1% were correctly registered in GP and community pharmacy records, respectively. There was no correlation between registration status in the hospital EHR and registration status in GP practices or community pharmacies. CONCLUSIONS: The percentage of correct registration of bariatric surgery in hospital, GP, and community pharmacies is low. To avoid doctors prescribing and pharmacists dispensing drugs to post-bariatric patients without knowing that they have undergone this procedure, better registration of the contraindication is required to enable optimal use of clinical decision support systems for the pharmacotherapy of patients after bariatric surgery.

Evaluating the Spanish readability of American Society for Metabolic and Bariatric Surgery (ASMBS) Centers of Excellence (COE) websites.

BACKGROUND: Healthcare disparities continue to be an ongoing struggle in Bariatrics. Limited availability of Spanish online material may be a correctible barrier for accessibility to Hispanic patients. We sought to evaluate accredited Bariatric Centers of Excellence (COE) for Spanish readability via their websites to determine accessibility for Spanish speakers. METHODS: This was an internet research study. 103 COE accredited by American Society for Metabolic and Bariatric Surgery (ASMBS) and the American College of Surgeons (ACS) were evaluated and assigned one of five Spanish Visibility Categories. The United States was divided into 4 regions. Regional Spanish visibility was calculated by dividing each category count by the number of institutions in each region. County Spanish-speaking populations were obtained from the US Census Bureau's 2009-2013 American Community Survey. Differences in their distributions across the Spanish Visibility Categories were investigated using the Mann-Whitney U test. RESULTS: 25% of websites were translatable to Spanish, and a regional discrepancy was found with 61% translatable in the West, 19% in Northeast, 19% in Midwest, and 15% in South. Median Spanish-speaking population was higher in counties where websites were translatable to Spanish than where websites were not translatable. CONCLUSION: Healthcare disparities in Bariatrics continue to be an ongoing struggle. We suggest that Spanish readability for ASMBS ACS COE websites should be improved regardless of geographic differences in Spanish-speaking populations. We believe it would be valuable for these websites to have standards for readability of Spanish and other languages.

Implementation of entrustable professional activities into fellowship council accredited programs: a pilot project.

OBJECTIVE: The Fellowship Council (FC) is transitioning to a competency-based medical education (CBME) model, including the introduction of Entrustable Professional Activities (EPAs) for training and assessment of Fellows. This study describes the implementation process employed by the FC during a ten-month pilot project and presents data regarding feasibility and perceived value. METHODS: The FC coordinated the development of EPAs in collaboration with the sponsoring societies for Advanced GI/MIS, Bariatrics, Foregut, Endoscopy and Hepatopancreaticobiliary (HPB) fellowships encompassing the preoperative, intraoperative, and postoperative phases of care for key competencies. Fifteen accredited fellowship programs participated in this project. The assessments were collected through a unique platform on the FC website. Programs were asked to convene a Clinical Competency Committee (CCC) on a quarterly basis. The pilot group met monthly to support and improve the process. An exit survey evaluated the perceived value of EPAs. RESULTS: The 15 participating programs included 18 fellows and 106 faculty. A total of 655 assessments were initiated with 429 (65%) completed. The average (SD) number of EPAs completed for each fellow was 24(18); range 0-72. Intraoperative EPAs were preferentially completed (71%). The average(SD) time for both the fellow and faculty to complete an EPA was 27(78) hours. Engagement increased from 39% of fellows completing at least one EPA in September to 72% in December and declining to 50% in May. Entrustment level increased from 6% of EPAs evaluated as "Practice Ready" in September to 75% in June. The exit survey was returned by 63% of faculty and 72% of fellows. Overall, 46% of fellows and 74% of program directors recommended full-scale implementation of the EPA framework. CONCLUSION: A competency-based assessment framework was developed by the FC and piloted in several programs. Participation was variable and required ongoing strategies to address barriers. The pilot project has prepared the FC to introduce CBME across all FC training programs.

Not deep enough: Modeling the effect of shallow placement of the DaVinci Xi "bariatric" long trocar on the muscular abdominal wall.

INTRODUCTION: The DaVinci Xi Robotic Surgical System (Xi) long cannula (Intuitive Surgical Company, Sunnyvale, CA) provides five additional centimeters of distal length compared to the standard Xi trocar. The extra length allows the cannula to traverse prohibitively thick body wall tissue. Our aims are to quantitatively model the consequences of not preserving the rotational centerpoint of motion (RCM) at the muscular abdominal wall. This is an essential tenet in robotic surgery; it is violated with shallow placement of the long trocar. This leads to unchecked, unnoticed blunt widening of port sites by the robotic arm, increasing hernia risk. METHODS: We begin with an exploration of the schematic of the Xi robotic arm as patented by Intuitive (U.S. Patent #5931832). We trigonometrically model the lateral displacement of the abdominal wall at the trocar site with respect to vertical trocar shallowness, instrument tip depth, and instrument tip lateral motion from neutral midline. RESULTS: The rigid parallelogram movement structure of the Xi preserves the RCM at the thick black marker printed on every Xi cannula. By limitation of design, both long and standard trocars must have this marker at the exact same distance from their proximal end. The value ranges of our model parameters (presuming a reasonable maximum orientation angle of 45° from midline) are: trocar shallowness [1 cm, 7 cm]; instrument tip depth [0 cm, 20 cm]; instrument tip lateral movement [0.0 cm, 14.1 cm]. Abdominal wall displacement increased proportionally as each instrument tip parameter reached its maximum deviation from the orthogonal midline as described in the plot figure. Maximal wall displacement at maximal shallowness was approximately 7.0 cm. CONCLUSION: Robotic surgery revolutionizes modern operation, particularly within bariatrics. However, the current Xi arm design disallows a true long trocar to be used safely without compromising the RCM, thereby risking hernia development.

Roux-en-Y gastric bypass and sleeve gastrectomy as revisional bariatric procedures after adjustable gastric banding: a retrospective cohort study.

INTRODUCTION: The frequency of revisional bariatric surgery is increasing, but its effectiveness and safety are not yet fully established. The aim of our study was to compare short-term outcomes of primary (pRYGB and pSG) and revisional bariatric surgeries (rRYGB and rSG). METHODS: We performed a retrospective cohort study assessing all patients submitted to primary and revisional (after a failed AGB) RYGB and SG in 2019. Each patient was followed-up at 6 months and 12 months after surgery. We compared pRYGB vs. rRYGB, pSG vs. rSG and rRYGB vs. rSG on weight loss, surgical complications, and resolution of comorbidities. RESULTS: We assessed 494 patients, of which 18.8% had undergone a revisional procedure. Higher weight loss at 6 and 12 months was observed in patients undergoing primary vs. revisional procedures. Patients submitted to rRYGB lost more weight than those with rSG (%EWL 12 months = 82.6% vs. 69.0%, p < 0.001). Regarding the resolution of obesity-related comorbidities, diabetes resolution was more frequent in pRYGB than rRYGB (54.2% vs. 25.0%; p = 0.038). Also, 41.7% of the patients who underwent rRYGB had dyslipidemia resolution vs. 0% from the rSG group (p = 0.035). Dyslipidemia resolution was also more common in pSG vs. rSG (68.6% vs. 0.0%; p = 0.001). No significant differences in surgical complications were found. CONCLUSION: Revisional bariatric surgery is effective and safe treating obesity and related comorbidities after AGB. Primary procedures appear to be associated with better weight loss outcomes. Further prospective studies are needed to better understand the role of revisional bariatric surgery.

Incidence and risk factors of symptomatic Petersen's hernias in bariatric and upper gastrointestinal surgery: a systematic review and meta-analysis.

PURPOSE: The aim of this study was to investigate the actual incidence of symptomatic Petersen's hernias (PH) as well as identify risk factors for their occurrence. METHODS: Search was performed in Medline (via PubMed), Web of Science, and Cochrane library, using the keywords "Petersen Or Petersen's AND hernia" and "Internal hernia." Only studies of symptomatic PH were eligible. Fifty-three studies matched our criteria and were included. Risk of bias for each study was independently assessed using the checklist modification by Hoy et al. Analysis was performed using random-effects models, with subsequent subgroup analyses. RESULTS: A total of 81,701 patients were included. Mean time interval from index operation to PH diagnosis was 17.8 months. Total small bowel obstruction (SBO) events at Petersen's site were 737 (0.7%). SBO incidence was significantly higher in patients without defect closure (1.2% vs 0.3%, p < 0.01), but was not significantly affected by anastomosis fashion (retrocolic 0.7% vs antecolic 0.8%, p = 0.99). SBO incidence was also not significantly affected by the surgical approach (laparoscopic = 0.7% vs open = 0.1%, p = 0.18). However, retrocolic anastomosis was found to be associated with marginally, but not significantly, increased SBO rate in patients with Petersen's space closure, compared with the antecolic anastomosis (p = 0.09). CONCLUSION: PH development may occur after any gastric operation with gastrojejunal anastomosis. Contrary to anastomosis fashion and surgical approach, defect closure was demonstrated to significantly reduce SBO incidence. Limitations of this study may include the high heterogeneity and the possible publication bias across the included studies.

Bariatric and metabolic surgery in patients with low body mass index: an online survey of 543 bariatric and metabolic surgeons.

BACKGROUND: Metabolic and bariatric surgery (MBS) in patients with low body mass index patients is a topic of debate. This study aimed to address all aspects of controversies in these patients by using a worldwide survey. METHODS: An online 35-item questionnaire survey based on existing controversies surrounding MBS in class 1 obesity was created by 17 bariatric surgeons from 10 different countries. Responses were collected and analysed by authors. RESULTS: A total of 543 bariatric surgeons from 65 countries participated in this survey. 52.29% of participants agreed with the statement that MBS should be offered to class-1 obese patients without any obesity related comorbidities. Most of the respondents (68.43%) believed that MBS surgery should not be offered to patients under the age of 18 with class I obesity. 81.01% of respondents agreed with the statement that surgical interventions should be considered after failure of non-surgical treatments. CONCLUSION: This survey demonstrated worldwide variations in metabolic/bariatric surgery in patients with class 1 obesity. Precise analysis of these results is useful for identifying different aspects for future research and consensus building.

Small intestine-targeted endoscopic bariatrics: Current status and future perspectives.

The global obesity epidemic shows no signs of slowing down. Endoscopic bariatric and metabolic therapies (EBMTs) are being increasingly adopted as treatment options for obesity and obesity-related comorbidities, due to their minimally invasive nature and ease of delivery. According to the site of action along the gastrointestinal tract, EBMTs can be divided into two categories: gastric EBMTs, and small intestine-targeted EBMTs. Unlike gastric EBMTs, which work through a volume-restricting mechanism leading to early satiety and reduced caloric intake, small intestine-targeted EBMTs can be metabolically beneficial through foregut and/or hindgut pathways independent of weight loss, and therefore have great potential for the treatment of obesity-related metabolic comorbidities such as type 2 diabetes. Although none of the small intestine-targeted EBMTs have been approved by the US Food and Drug Administration to date, their clinical efficacy and safety have been extensively explored in investigational trials. This review aims to summarize and provide a comprehensive understanding of small intestine-targeted EBMTs in clinical and preclinical settings, and to further discuss their potential mechanisms of action.

Bariatric endoscopy, care-curative medicine and legal conflicts. Spanish Bariatric Endoscopy Group (Gettemo-SEED) Positioning.

Bariatric endoscopy treats obesity as a disease, in addition to its multiple associated comorbidities, so it should be considered in the "care-curative" field and not as "satisfying, voluntary or outcoming" medicine. Insufficient weight loss cases, or complications may occur. This, in parallel with the greater diffusion of these techniques, results an increase in the risk of complaints and judicial claims, which will presumably grow during next years. In this sense, we consider that all Bariatric Endoscopic Units working with medical-scientific rigor, must be able to be accredited and have legal support by the Scientific Societies. We propose to create a Medical-Legal Advisory Committee, composed of a medical team and a specialized law firm, which allows advising and guiding the endoscopist when incurring in a conflict.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

Evaluation of High-Interval Education to Improve Outcomes for Bariatric Patients With Health Disparities.

A correlation of health disparities, socioeconomic barriers, and health literacy were hypothesized as causative factors of poor weight loss, weight regain, and loss to clinical follow-up in postbariatric patients. This study explored nurse practitioner-led interventions to address health disparities and improve outcomes. This pilot project evaluated 3-month weights of an intervention cohort as compared with a retrospective cohort. The intervention cohort received a weekly educational phone call from the clinical nurse practitioner. Quantitative data based on 3-month weights reveal an average excess body weight percentage lost at the 3-month postoperative clinical visit (36.54 ± 0.11, p = .2929) in the retrospective cohort ( n = 30) as compared with the intervention cohort ( n = 30; 33.46 ± 0.11, p = .2929). Participants responding to the barriers screening tool did not correspond with the actual needs represented by the population. Food access and transportation were leading factors affecting weight loss. This project revealed implications including the need for development of bariatric-specific social needs assessments, the need to explore telehealth as a modality to improve patient education, the need to modify education to overcome deficits in health literacy. Findings also validate the role of the nurse practitioner as a leader of multidisciplinary care teams.

The Bariatric Pyramid: A framework for therapeutic targets.

The Bariatric Pyramid is a model which serves to explain the goals of obesity management, act as a milestone for monitoring of therapy, and to benchmark the utility of various anti-obesity medications and interventions. Built upon a base of sustainability, it lists three more desired aspects of care: sufficiency (sufficient strength) safety and security. Each of the four aspects of the pyramid: sustainability, sufficiency safety and security have three angles, which allows the reader to understand them easily. The model that we propose is useful in training health care professionals, in therapeutic patient education, for assessing various anti-obesity therapies, and in reaching the right decision while managing obesity.

Innovative Bariatric Procedures and Ethics in Bariatric Surgery: the IFSO Position Statement.

With the rise in obesity and bariatric procedures worldwide, there has been a surge in new and innovative procedures that has been increasingly offered to patients. In this position statement, IFSO highlights the importance of surgical ethics in innovation and when offering new procedures. Furthermore, the task force reviewed the current literature to describe which procedures can be offered as mainstream outside research protocols versus those that are still investigational and need further data.

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis.

Obesity is strongly associated with nonalcoholic fatty liver disease as well as advanced forms of the disease such as nonalcoholic steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. While lifestyle and diet modifications have been the cornerstone of treatment for NASH thus far, they are only effective for less than half of the patients. New endoscopic bariatric therapies (EBTs) have already proved to be safe and effective for the treatment of obesity and type 2 diabetes mellitus, and may provide an intermediate, less invasive, cost-effective option for patients with NASH. In this review, we aim to describe the data and evidence as well as outline future areas of development for endobariatric therapies for the treatment of NASH. In conclusion, EBTs present an effective and safe therapeutic modality for use in the growing pandemic of obesity-related liver disease and should be investigated further with large-scale trials in this patient population.

Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Weight loss via lifestyle intervention remains the mainstay of treatment for nonalcoholic fatty liver disease (NAFLD). Endoscopic bariatric and metabolic therapies (EBMTs) have recently been developed as an alternative treatment option for obesity. This study aimed to assess the effect of FDA-approved EBMTs on NAFLD. METHODS: We searched MEDLINE, EMBASE, Web of Science and Cochrane Central through December 2020 for studies that assessed changes in liver outcomes following EBMT. Primary Outcomes: Liver fibrosis. SECONDARY OUTCOMES: Liver biochemistry, steatosis, NAFLD histological changes and insulin sensitivity. The Grading of Recommendations, Assessment, Development, and Evidence (GRADE) approach was conducted to assess quality of evidence. RESULTS: Of 4994 potential studies, 18 studies with 863 patients were included. Average weight loss was 14.5% of initial weight at a 6-month follow-up. Primary outcomes: Following EBMT, liver fibrosis significantly reduced by standardized mean difference (SMD) of 0.7 (95% CI, 0.1, 1.3; P = .02). SECONDARY OUTCOMES: There were significant improvements in other NAFLD surrogates including alanine aminotransferase (-9.0 U/L; 95% CI, -11.6, -6.4; P < .0001), hepatic steatosis (SMD: -1.0; 95% CI, -1.2, -0.8; P < .0001) and histologic NAFLD activity score (-2.50; 95% CI, -3.5, -1.5; P < .0001). Other metabolic parameters including insulin resistance and waist circumference also significantly improved. The overall quality of the evidence for primary outcomes was low to very low. CONCLUSIONS: EBMTs appear effective at treating NAFLD with significant improvement in liver fibrosis. Given the worsening NAFLD pandemic and limitations of currently available therapies, EBMTs should be further investigated as a potential treatment option for this patient population.

Comparison of Soluble Gelatin Sponge Particles and Tris-acryl Gelatin Microspheres for Bariatric Arterial Embolization in Swine.

The purpose of this study was to compare complications and the number of ghrelin-expressing cells (GECs) after bariatric arterial embolization (BAE) using soluble gelatin sponge particles (SGSs) or tris-acryl gelatin microspheres (MSs) in swine. Twelve swine underwent embolization of gastric fundal arteries with SGSs (n = 4) or MSs (n = 4) or underwent saline infusion (n = 4, control group). One week later, the number of gastric ulcers and the percentage of GECs were compared among the 3 groups. There were no ulcers in the SGS and control groups. Two swine in the MS group had 4 large ulcers (12-50 mm in size). The mean percentages of GECs were significantly lower in the SGS (2.7% ± 0.9%) and MS (2.5% ± 1.0%) groups compared with the control group (3.7% ± 1.3%; P = .038 and P = .016, respectively). SGSs may be safer than MSs for BAE while inducing a similar reduction of GECs in swine.